Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department

Official title

RELIEF-RC: Relief Efficacy of LIdocaine Versus morphinE For Acute Renal Colic in the Emergency Department

Overview

The opioid epidemic continues to be a major public health crisis in the United States. According to the Center for Disease Control, approximately 8 million Americans reported misusing prescription opioids in 2023, with over 5 million Americans reporting that they suffer from opioid use disorder. The United States government estimates that 105,000 people died from drug overdose in 2023, and approximately 80,000 of those deaths can be attributed to opioids (\~76%). In acknowledgement of the opioid crisis, we wish to contribute to ongoing efforts to reduce unnecessary and excessive opioid prescription. In 2012, researchers in Iran published a randomized controlled trial comparing intravenous (IV) lidocaine to IV morphine for acute renal colic, reporting that 90% patients responded "successfully" in the lidocaine group versus 70% in the morphine group. They also concluded that there was a statistically significant difference between pain scores between the two groups at all time points, favoring the lidocaine group. However, the study was conducted at a single emergency department in Tabriz, Iran, with a relatively homogenous patient population, and the researchers did not explicitly define their primary outcome variable for what constituted a "successful" response in the treatment groups. The investigators of this study aim to build upon this preliminary evidence by recruiting a more diverse population to improve generalizability and by predefining pain-reduction thresholds to allow for more meaningful comparison between the interventions.

Detailed description

Purpose

● To determine whether IV lidocaine is more efficacious than IV morphine in decreasing or resolving acute renal colic pain refractory to initial treatment with parenteral ketorolac

Primary Objective ● To compare the efficacy of IV lidocaine versus IV morphine in achieving at least 50% reduction of pain score at 30 minutes for renal colic requiring rescue medication after initial treatment with parenteral ketorolac

Secondary Objectives

* To compare reduction in pain scores at 15, 60, and 90 minutes between the two intervention groups; * To determine if there is a statistically significant difference in emergency department length of stay (ED LOS) between the two intervention groups * To determine if there is a statistically significant difference in need for further rescue medications between the two intervention groups * To determine the incidence of adverse effects between the two intervention groups * To evaluate whether there is a correlation between age and efficacy of treatment between the two intervention groups

Study Design This study is a prospective randomized controlled trial. Study participants will be randomized to receive either IV lidocaine or IV morphine if they fail initial standard treatment with parenteral ketorolac for suspected acute renal colic.

Study Date Range and Duration The estimated study period will be from 1/1/2026 to 12/31/2027.

The study will be carried out for two calendar years, and may be halted early when sufficient participant enrollment has occurred.

Number of Study Sites

1. Loma Linda University Medical Center - Adult Emergency Department (Adult ED) 2. Loma Linda University Medical Center - East Campus Advanced Urgent Care (AUC)

Primary Outcome Variables

● Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 30 minutes

Secondary and Exploratory Outcome Variables

* Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes * Adverse events attributed to IV lidocaine or IV morphine * ED LOS * Need for additional rescue medications after either IV lidocaine or IV morphine

Study Population Study participants will be enrolled from patients who have suspected renal colic as determined by the treating clinician at the Loma Linda Adult ED or AUC.

Number of Participants This study seeks to enroll at least 248 patients over the study period, with at least 190 patients required to achieve a standard statistical power of 80%. Patients will be randomized into two groups - 124 patients per group.

Study Schedule All data and information, including consent and screening, will be gathered during the course of a patient's single visit at the Loma Linda Adult ED or AUC.

Interventions

• Drug Lidocaine
  We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.
• Drug Morphine 0,1 mg/kg
  We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.

Primary outcome measures

• Response to treatment [Time frame: 30 minutes after completion of medication administration]

Secondary outcome measures (4)

• Response to treatment [Time frame: 15, 60, 90 minutes after completion of medication administration]
• Adverse events [Time frame: From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours]
• Emergency Department Length of Stay [Time frame: From time of patient registration in the emergency department to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours]
• Rescue medications [Time frame: From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours]

Eligibility criteria

Inclusion criteria

In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:

• Age ≥ 18 years at time of visit
• Able and willing to consent for participation in study
• Documentation of suspected renal colic as primary complaint as evidenced by reported flank pain, back pain, abdominal pain, or groin pain, or as determined by the treating clinician
• Requires additional treatment due to inadequate analgesia or clinical suspicion of unsafe discharge secondary to pain after initial treatment with parenteral ketorolac

Exclusion criteria

Any individual who meets any of the following criteria will be excluded from participation in this study:

• Age < 18 years
• Use of analgesia for renal colic within 6 hours prior to clinician evaluation
• Inability or unwillingness to consent for participation in study
• Experienced a severe adverse event that required clinician intervention after initial treatment with parenteral ketorolac
• Documented history of allergic or anaphylactic reaction to NSAIDs, lidocaine, or morphine
• Documented history of cardiac arrhythmias
• Documented history of chronic use of opioid medications for unrelated diagnoses
• Currently pregnant
• Documented history of end-stage renal or hepatic dysfunction
• Clinical contraindications to NSAIDs, lidocaine, or morphine per clinician discretion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Garnett MF, Minino AM. Drug Overdose Deaths in the United States, 2003-2023. NCHS Data Brief. 2024 Dec;(522):1. doi: 10.15620/cdc/170565. PMID 40623710
• Krieger A, Zaidan N, Zhao P, Borin JF, Goldfarb DS. Questionable role of opioids for analgesia in renal colic and its urological interventions. BJUI Compass. 2025 Jun 11;6(6):e70038. doi: 10.1002/bco2.70038. eCollection 2025 Jun. PMID 40503371
• Seyhan AU, Yilmaz E. Treatment of Renal Colic by Nerve Blockade with Lidocaine Versus Intravenous Dexketoprofen. J Coll Physicians Surg Pak. 2021 Aug;31(8):921-925. doi: 10.29271/jcpsp.2021.08.921. PMID 34320708
• Motov S, Fassassi C, Drapkin J, Butt M, Hossain R, Likourezos A, Monfort R, Brady J, Rothberger N, Mann SS, Flom P, Gulati V, Marshall J. Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED. Am J Emerg Med. 2020 Feb;38(2):165-172. doi: 10.1016/j.ajem.2019.01.048. Epub 2019 Jan 30. PMID 30770244
• Motamed H, Maleki Verki M. Intravenous Lidocaine Compared to Fentanyl in Renal Colic Pain Management; a Randomized Clinical Trial. Emerg (Tehran). 2017;5(1):e82. doi: 10.22037/emergency.v5i1.18894. Epub 2017 Oct 23. PMID 29201964
• Firouzian A, Alipour A, Rashidian Dezfouli H, Zamani Kiasari A, Gholipour Baradari A, Emami Zeydi A, Amini Ahidashti H, Montazami M, Hosseininejad SM, Yazdani Kochuei F. Does lidocaine as an adjuvant to morphine improve pain relief in patients presenting to the ED with acute renal colic? A double-blind, randomized controlled trial. Am J Emerg Med. 2016 Mar;34(3):443-8. doi: 10.1016/j.ajem.2015.11. PMID 26704774
• Soleimanpour H, Hassanzadeh K, Vaezi H, Golzari SE, Esfanjani RM, Soleimanpour M. Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department. BMC Urol. 2012 May 4;12:13. doi: 10.1186/1471-2490-12-13. PMID 22559856
• Eaton SH, Cashy J, Pearl JA, Stein DM, Perry K, Nadler RB. Admission rates and costs associated with emergency presentation of urolithiasis: analysis of the Nationwide Emergency Department Sample 2006-2009. J Endourol. 2013 Dec;27(12):1535-8. doi: 10.1089/end.2013.0205. Epub 2013 Nov 19. PMID 24251430

Identifiers

NCT: NCT07536594 · 5260095

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗